Lead Production Technician

Main Responsibilities

• Follows SOPs and Batch Records (BRs) to produce commercial drug substance material.
• Sets up, cleans, and operates manufacturing equipment in a cGMP environment for Flublok/Panblok drug substance, including upstream and/or downstream processes.
• Maintains materials required for production and plans ahead according to the B55 production schedule.
• Monitors production activities with emphasis on safety, quality, efficiency, and cost.
• Supports housekeeping, facility cleaning, and daily manufacturing needs to maintain an inspection-ready state.
• Supports off-shift work as needed.

Quality, Compliance & Documentation

• Maintains thorough knowledge of cGMP requirements and helps others understand and apply them.
• Accurately and timely completes quality documentation including eBRs, logbooks, deviation investigations, and other required records.
• Identifies deviations, aids in investigations, and performs root cause analysis; ensures implementation of effective corrective and preventative actions (CAPAs).
• Initiates change controls and CAPAs and follows them through to completion.
• Writes, reviews, and revises eBRs, SOPs, and SWIs as needed.
• Supports CFR compliance, FDA audit readiness, and Pre-Approval Inspection (PAI) preparedness.

Leadership, Subject Matter Expertise & Continuous Improvement

• Serves as Lead Operator, Room Lead, or Subject Matter Expert (SME), ensuring quality and right-first-time efforts across one or more processing areas in B55.
• Solves production issues, understands next steps, and guides the team through completion; informs management of production problems and recommends solutions.
• Identifies areas of deficiency and opportunities for continuous incremental improvement, with emphasis on reducing operator errors.
• Systmatically breaks down problems using proven standard approaches.
• May be responsible for scheduling staff assignments and addressing inquiries related to media, reagents, supplies, intermediates, and equipment.
• Understands the entire manufacturing process, including the sciences and technologies behind each process step, and demonstrates follow-through in moving processes forward.
• Aware of other departments and business areas and how they contribute to the overall objective of delivering products and services.

Training & Development

• Provides training, instruction, guidance, and direct technical support to operations staff on proper work procedures, equipment use, cGMPs, safe work techniques, and ERP systems.
• Maintains qualified trainer status.
• Completes at least one developmental class annually outside of core competencies and works to complete all assigned training modules.
• Works with management to identify development opportunities for technician staff.

Safety

• Follows all safety procedures to ensure personal safety and the safety of others.
• Participates in monthly safety meetings and actively engages in safety walkthroughs.
• Reports all safety issues, concerns, incidents, and near misses to team leadership.
• Provides input on potential safety issues and contributes ideas for corrective and preventative actions.
• Works with the safety and leadership team to secure resources needed to address safety issues in a timely manner and to implement effective resolutions.
• Actively and effectively communicates safety initiatives and helps others understand and comply with them; ensures training is completed on all safety implementations.
• Ensures compliance with site safety and HR policies and communicates issues immediately.